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Sdtm Jobs (NOW HIRING)

SDTM datasets * ADaM datasets * Tables, Listings, and Figures (TLFs) * Ensure all deliverables are compliant with CDISC standards and regulatory requirements * Support regulatory submissions (e.g ...

Collaborate with Data Management to ensure alignment with data standards (CDISC, SDTM where applicable). * Perform User Acceptance Testing (UAT) and support database releases and migrations. * Ensure ...

Develop and maintain SAS programs to create SDTM and ADaM datasets and TFLs, and perform QC of SDTM, ADaMs and TFLs. * Produce Define XML/PDFs, Analysis Results Metadata (ARM), annotated CRFs and ...

Principal Statistical Programmer

Durham, NC · On-site

$98.20K - $273.20K/yr

SDTM datasets * ADaM datasets * Tables, Listings, and Figures (TLFs) * Ensure all deliverables are compliant with CDISC standards and regulatory requirements * Support regulatory submissions (e.g ...

Develop SDTM and ADaM datasets and supporting documentation.Prepare and review mapping specifications and annotated case report forms (CRFs).Perform quality control and validation activities for ...

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How much do sdtm jobs pay per hour?

As of May 29, 2026, the average hourly pay for sdtm in the United States is $54.04, according to ZipRecruiter salary data. Most workers in this role earn between $41.59 and $68.03 per hour, depending on experience, location, and employer.

What is an SDTM job?

An SDTM job involves working with the Study Data Tabulation Model (SDTM), a standardized format required by regulatory agencies like the FDA for clinical trial data submission. Professionals in this role convert raw clinical data into SDTM-compliant datasets, ensuring consistency, traceability, and adherence to regulatory guidelines. Responsibilities often include data mapping, validation, and quality control to facilitate efficient review by regulatory bodies.

What are the key skills and qualifications needed to thrive in the Sdtm position, and why are they important?

To thrive as an SDTM (Study Data Tabulation Model) Programmer, you need a strong background in clinical data standards, SAS programming, and an understanding of FDA submission requirements, usually supported by a degree in a scientific, mathematical, or computer-related field. Expertise with CDISC standards, SDTM IGs (Implementation Guides), and tools such as Pinnacle 21 Validator or JReview is essential. Strong analytical skills, attention to detail, effective communication, and the ability to collaborate across multidisciplinary teams are vital soft skills. These competencies are crucial for ensuring high-quality, regulatory-compliant clinical trial data that supports successful drug approval processes.

What are the typical daily responsibilities of an SDTM Programmer in a clinical research organization?

As an SDTM Programmer, your daily tasks often include mapping raw clinical data into SDTM domains, validating datasets for compliance with CDISC standards, and generating documentation and specifications for regulatory submissions. You’ll frequently work with clinical data managers, statisticians, and other programmers to ensure data integrity and resolve any data-related queries that arise. Collaboration and timely troubleshooting are key, as your work supports the efficient progression of clinical studies through regulatory review. The role tends to be dynamic and deadline-driven, making organizational skills and adaptability important for success.
What cities are hiring for Sdtm jobs? Cities with the most Sdtm job openings:
What are the most commonly searched types of Sdtm jobs? The most popular types of Sdtm jobs are:
What states have the most Sdtm jobs? States with the most job openings for Sdtm jobs include:
Infographic showing various Sdtm job openings in the United States as of May 2026, with employment types broken down into 91% Full Time, and 9% Contract. Highlights an 75% Physical, 1% Hybrid, and 24% Remote job distribution, with an average salary of $112,399 per year, or $54 per hour.
Principal Developer, Data Visualization and Application Development

Principal Developer, Data Visualization and Application Development

Biogen

Cambridge, MA • On-site, Remote

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 25 days ago


Biogen rating

9.2

Company rating: 9.2 out of 10

Based on 18 frontline employees who took The Breakroom Quiz

2nd of 70 rated pharmaceutical


Job description

Duties:

Create and maintain applications for required projects within the Data Visualization and Application Development team.

Responsible for creating and maintaining macros and programs used to create statistical programming deliverables, including SDTM.

Integrate new data standard releases with clinical study level SDTM deliverables to ensure seamless integration.

Develop programs and utilities using various tools and languages to support integration.

Maintain existing and develop new metadata tools to integrate across the systems in the study data flow and enable automation of SDTM including supporting overall Biogen efforts in streamlining data flow and data review.

Create and maintain programs to support and enhance under-represented population in Biogen's clinical trials.

Create and develop Dashboard for overall utilization and workload of functional service providers for better assessment and redistribution of tasks and ownership. Develop, project manage and maintain SharePoint site for functional groups.

Work on complex algorithms and coding to integrate all SDTM specifications and database specifications.

Build governance database to create a repository of all governance requests such that the governance requests and guidance can be tracked.

Create and provide training on "R" to SAS programmers.

Telecommuting permitted up to 20%.

Minimum Requirements:

Employer will accept a Bachelor's degree (or foreign equivalent) in Data Analytics, Information Systems, Information Technology or related field, and 4 years of experience in the job offered or in a Principal Developer, Data Visualization and Application Development-related occupation.

Position requires 24 months of experience in the following:

Working with CDISC data standards to ensure compliance and consistency of data analysis in clinical research.

Developing applications that facilitate data or components of a Clinical Study Report (CSR) intended for submission to a regulatory body.

Working within a GxP-compliant computing environment including knowledge of Good Clinical Practice (GCP) requirements for software.

Regulatory requirements for software used in clinical trials and submissions, including familiarity with FDA 21 CFR Part 11.

Position also requires 4 years of experience in the following:

Developing and optimizing R programs using packages including dplyr, data.table, and tidyr to efficiently extract, transform, and analyze large datasets, integrating results for advanced statistical modeling and visualization.

Creating dynamic visualizations including Plotly, ggplot2, RColorBrewer, and Leaflet to enhance data interpretation.

Generating and maintaining markdown validation reports using knitr.

Developing custom R functions using packages including purrr, dplyr, and stringr to enhance reusability, streamline workflows, and standardize analytical processes across projects.

Building data-driven applications with the R Shiny framework and automating reporting dashboards, ensuring seamless user interactivity and functionality.

Performing rigorous QC/QA validation checks using R packages and producing consolidated report outputs.

Upholding strong documentation practices, adhering to best coding standards in R, and managing version control with Azure DevOps or GitHub Repos.

Independently managing software projects and moving them to completion and demonstrating project management skills in a data/software environment.

Assessing data models and then applying them to existing data.

Working with relevant stakeholders to identify user requirements and working independently to create/optimize solutions.

Telecommuting permitted up to 20%.

Salary: $122,000 to $177,00/year

Hours: 9:00 a.m. to 5:00 p.m. Monday - Friday, approximately 40 hours/week.


Job Level: Management


Additional Information

The base compensation range for this role is: -


Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:

  • Medical, Dental, Vision, & Life insurances
  • Fitness & Wellness programs including a fitness reimbursement
  • Short- and Long-Term Disability insurance
  • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
  • Up to 12 company paid holidays + 3 paid days off for Personal Significance
  • 80 hours of sick time per calendar year
  • Paid Maternity and Parental Leave benefit
  • 401(k) program participation with company matched contributions
  • Employee stock purchase plan
  • Tuition reimbursement of up to $10,000 per calendar year
  • Employee Resource Groups participation

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.


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About Biogen

Sourced by ZipRecruiter

At Biogen, our mission is clear - we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Together, our employees create, commercialize, and manufacture transformative therapies for our patient population.

Industry

Scientific research and development services

Company size

5,001 - 10,000 Employees

Headquarters location

Cambridge, MA, US

Year founded

1978

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